Site Lead

About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role

The Site Lead at Foresight Diagnostics will be responsible for oversight of laboratory operations and testing at Foresight’s Boulder, Colorado facility and will collaborate to integrate cross functional laboratory requirements to deliver operational quality and efficiency that meets all regulatory guidelines for Foresight’s breadth of laboratory testing. The Site Lead will hold certifications such that they could perform testing in the CLIA laboratory (including patient samples from California and New York) and receive delegation authority from Foresight’s Laboratory Director.  This is an advanced level role that would suit an experienced leader who has managed cross functional laboratory teams processing high-complexity NGS based testing through all phases of the business life cycle. This is a full-time position based in Colorado working standard business hours in a startup company, that will require the flexibility to work diverse schedules, including evenings, weekends, and holidays for critical deliverables. This position reports to the SVP, Business and Laboratory Operations and Strategy. 

Responsibilities 

• Provides onsite operational leadership to Foresight’s laboratory teams through the integration of operational wet lab processes and is responsible for building efficient and high quality laboratory workflows and protocols that maximize productivity, minimize turnaround times, and optimize resource utilization. 

• Maintain proficiency in wet lab processes to provide testing support, if/when needed and to ensure quality and efficacy of laboratory training programs.

• Stakeholder in the development and technical transfer of new products (assays, automation, software, etc.) to the production environment with the goal of successful operational implementation and product launch, revenue enhancement, cost expense reduction, and efficient, high quality testing. 

• Oversees resource allocation including space, capital equipment, scientific instrumentation and staff for the Boulder, CO facility operating as the authority among functional leadership.   

• Responsible for laboratory adherence to quality standards and policies as it relates to laboratory operations and regulations (GxP, CAP/CLIA, NYSDOH, ISO15189)

• Collaborate with the Director of Supply Chain on S&OP to ensure ability to meet regulated and translational research study schedules, clinical testing TAT requirements, and internal deadlines.

• Collaborate with Directors of Research, Development, Software and Bioinformatics to align on product requirements and implementation/tech transfer plans to enable launch of new products into production. 

• In collaboration with the SVP, Business and Laboratory Operations and Strategy, establish and track applicable laboratory metrics/key performance indicators to inform senior leadership on the health of laboratory operations. 

• Partner with Medical Affairs and Clinical Operations teams to implement defined processes to execute RFPs, clinical trials, and biobanking. 

• Participate in external communication with customers on translational research project kick off and subsequent status, QC results, delivery timeline, study results, etc. with a goal of maintaining a high standard of customer satisfaction. 

• Assist the Quality team and Laboratory Director with internal and external audits, and operate as the operations lead/POC for the production laboratory with an escalation path to the SVP, Business and Laboratory Operations and COO.

• Establish and maintain strong working relationships with cross functional leads to develop proactive communication mechanisms and support successful execution of integrated quarterly and yearly objectives. 

• Oversee, plan, and implement quality checks for laboratory testing and provide leadership and direction to ensure the highest standards for compliance.

• Troubleshoot